Evaluating a mobile-based intervention to promote the mental health of informal dementia caregivers in Singapore: Study protocol for a pilot two-armed randomised controlled trial

Background Informal caregivers of persons with dementia (PWD) often suffer adverse impacts on their mental health and require interventions for effective support. As they are often occupied with providing care, web-based interventions could be more convenient and efficient for them. However, there is currently a dearth of evidence-based mobile interventions to enhance the mental well-being of dementia caregivers locally, especially ones that are user-centered and culturally relevant. Hence, having designed an app based on feedback from local dementia caregivers, this study will evaluate the effectiveness of this mobile app in promoting the mental health of informal caregivers of PWD in Singapore. Methods A pilot two-armed randomised controlled trial will be conducted on 60 informal caregivers of PWD recruited via convenience and snowball sampling. Thirty participants will be assigned to the intervention group, while another 30 will be in a waiting-list control group. Questionnaires will be administered at baseline and one month after, with the primary outcome being the difference in the change of depressive symptoms among the two groups. Statistical analysis Primary analyses will follow the intention-to-treat principle and compare changes from baseline to the one-month follow-up time point relative to the control group. A repeated measures ANOVA will be conducted to examine differences between the groups over time. Significance To our knowledge, this is the first study in Singapore that seeks to promote the mental health of informal dementia caregivers through a mobile-based intervention. The findings can inform the development and evaluation of future evidence-based digital interventions for local informal caregivers of PWD to address the gap in availability of such resources for them. Trial registration ClinicalTrials.gov (NCT05551533). Registration date: September 22, 2022.

No.

Engaged in research IRB Approval Contact Person
There is nothing.

G1 What are the specific aims of this study?
The current project aims to 1) 1) design and develop a mobile-based multi-component intervention (i.e. an app) to promote mental health among informal caregivers of individuals with dementia in Singapore; 2) test the effectiveness of a mobile-based intervention (i.e.App) on promoting the mental health of informal caregivers of persons with dementia in Singapore through a pilot randomized control trial; 2) collect users' feedback on the intervention for its future improvements.
G2 What is the Hypothesis of this study?For qualitative studies, please provide the research question instead.
We hypothesize that the intervention (i.e. the App) would lower the reported depressive symptoms among local dementia caregivers.It will also improve their knowledge of dementia, caregiving efficacy, positive coping strategy, perceived positive aspects of caregiving, and their mental well-being; and reduce their caregiving burden, and level of anxiety, compared to the control group.
G3 Please describe the background to the current study proposal.Critically evaluate the existing knowledge and specifically identify the gaps that the proposed study is intended to fill.(Pinquart and Sörensen 2007).According to a previous systematic review, the aggregate prevalence of depression was reported to be 34% in a previous meta-analysis (Sallim, Sayampanathan et al. 2015).Once the informal caregiver develops a mental illness, the quality of care received by PWD would deteriorate and they might be institutionalized more quickly (Brodaty and Donkin 2009).This in turn will increase the financial burden of dementia.To address the above concerns and also to improve the life quality of PWD, promoting the mental health of dementia caregivers could be one essential endeavor.G4 Please provide details on (i) sample size and power calculation and (ii) the means by which data will be analyzed and interpreted.If this is a pilot study/qualitative study and no sample size calculation is performed, please provide a rationale on how the recruitment target is determined.
During the app design and development phase, focus group discussions will be conducted to collect feedback from potential users once the prototype of the app is ready.The planned sample size is 15, however, the final sample will be determined by data saturation.The group size will vary from 4-6 in considering their heavy involvement in the daily caregiving and the fact that we only have a short window period to collect such information (2-4 weeks).Since the current study mainly aims to explore the feasibility of the mobilebased intervention and its potential effectiveness among local informal caregivers of PWDs, a pilot study with 100 participants is planned for the randomized control trial (RCT) phase.Block randomization with a block size of 4 will be used to allocate the caregivers into either the intervention (n=50) or the waiting-list control condition (n=50).The sample size for the current pilot was determined with the following rationales: according to a previous methodological study, a sample size of 25 per arm is required for the pilot if the main trial will be designed with 90% power and two-sided 5% significance for an invention with a small effect size (Whitehead, Julious et al. 2016).However, since mobile-based intervention studies usually have high attrition rates -for example, an overall attrition rate of 43% was reported for app-based interventions for chronic disease according to a previous systematic review ( Meyerowitz-Katz, Ravi et al. 2020).As such, we have doubled the sample required from 25 to 50 to minimize the situation that there will be not enough samples for the analysis.After the RCT phase, participants in the intervention group will be invited to join a separate in-depth interview to collect their feedback and comments on the App and to explore how to improve the app in the future.We proposed 20 participants for this feedback phase.The final sample of this qualitative sub-study depends on data saturation.In other words, we will stop the recruitment if no new findings from the interviews even if we interview less than 20 participants.For the RCT, results will be reported following the Consolidated Standards of Reporting Trials (CONSORT) statement regarding eHealth (Eysenbach and Group 2011).Group information will not be disclosed to the statistician who is in charge of the final analysis, this is to blind the data analyst to reduce bias (Karanicolas, Farrokhyar et al. 2010).The primary analysis will follow the intention-to-treat principle and compare the outcome measures between the intervention vs. control groups.In addition, per-protocol analyses will also be conducted.More specifically, descriptive statistics will be used to describe the participants' profiles and their characteristics.The Mann-Whitney U-test will be used to assess any significant differences in the demographic data and clinical characteristics of the two groups.A multivariate repeated measured ANOVA will be performed to examine the differences between the two groups over time, with the adjustment of potential baseline differences.Effect size (i.e.Cohen's d) will also be calculated.All analysis will be conducted through SPSS V21 or SAS 9.4.For the qualitative data, the discussion and interviews will be audio-recorded and transcribed before the analysis.Thematic analysis will be conducted.Three researchers will work independently (i.e., Qi, Ellaisha, and Carol) to identify the key themes based on the first few transcripts with a subsequent discussion to refine the code themes, and then to develop the code-book.Disagreement will be solved through further discussion to achieve consensus.All qualitative analysis will be done through NVivo V.11.☐ Community Consent will be taken.

G5 Please provide a list of relevant references
☐ In addition, there will be use of anonymised data and/or biological materials from an independent third party for a specific study population.
Please elaborate why a combination of both informed consent and waiver of consent is required, and which population(s) will require waiver of consent and which population(s) will be able to give informed consent.For the FGD, the inclusion criteria are1) aged 21 or above; 2) Singapore citizen or permanent resident; 3) key caregiver who is currently taking care of a PWD; 4) able to read, write, and speak in English.For the RCT phase and the follow-up qualitative interview phases, the inclusion criteria are1) aged 21 or above; 2) Singapore citizen or permanent resident; 3) key caregiver who is currently taking care of a PWD; 4) scores 4 and above using the 4-item screening version Zarit Burden Interview; 5) has sufficient skills in using mobile apps; 6) able to read, write, and speak in English.
H4 Please list the exclusion criteria.Please state clearly, if pregnant women will be excluded from the study.*Click here for help Caregivers with the following conditions will be excluded from the current study1) pregnant;2) with vision or hearing problems;3) paid caregivers.The project will have three phases, including 1) app design and development, 2) intervention evaluation, and 3) seeking users' feedback.App design and development phase -during this phase, focus group discussions will be conducted by the study team members to collect feedback from potential users once the prototype of the app is ready.This information will be used to improve the app for another round before launching the final app during the intervention evaluation phase.The planned sample size is 15, however, the final sample will be determined by data saturation.The group size will vary from 4-6 in considering their usual heavy involvement in the daily caregiving and the fact that we only have a short window period to collect such information (2-4 weeks).The intervention evaluation phase -From this phase onwards, the final app will be provided to the users.In order to explore the feasibility and the potential effectiveness of the intervention (i.e., the final app), a pilot RCT with a waiting-list control condition will be conducted.The target sample size is 100 key dementia caregivers with relatively high baseline caregiver burden (scored 4 and above using the 4-item Screening Version Zarit Burden Interview (Bédard, Molloy et al. 2001)).Participants will be approached in IMH and satellite clinics, or referred by our collaborating clinicians.Public advertisement (e.g., online advertisement) will also be put up to reach potential participants.Once the participant agrees to participate, a study team member will go through the informed consent form with the participant either online via a video-conferencing platform such as zoom or in-person at a place convenient to the participant depending on the preference of the participant.After giving the signed consent, a screening session using the 4-item Zarit burden interview will be conducted.Participants with a score of 4 and above will be eligible and will be required to complete the baseline assessment directly.Block randomization with a block size of 4 will be used to allocate the caregivers into either the intervention (n=50) or the control conditions (n=50).An independent statistician who is not involved in the daily implementation will conduct the randomization, using a computer-generated random sequence table (i.e., AABB, ABAB, ABBA, BABA, BAAB, and BBAA).This is to ensure the allocation concealment.Caregivers in the intervention group will be instructed to use the app for at least 30 minutes per week over a period of 1 month.During this 1-month period, caregivers will be required to write about their positive thoughts and feelings on caregiving twice per week (i.e., one in the middle of the week, and the other one at the end of the week) using the 'Positive Reflections' feature, and this is the minimum requirement for the participants in the intervention group.For the networked peer support platform, users can post content, respond to others and get notifications when new interactions have taken place.Such interactions will provide natural triggers to bring users back to the platform and may as a result increase engagement (Fogg 2009).Meanwhile, an admin account will be kept by the research team to monitor the platform and ensure the overall supportive environment of the platform.Caregivers can use the app in ways that best fit their schedule and interests during the intervention period.Follow-up calls will be made by the study team to the intervention group participants every week to seek feedback, clarify potential confusion, and motivate them.Patient Health Questionnaire -9 (PHQ-9) will be used to assess the mental health status of users in the intervention group after week 2 to monitor their potential risk (and to report and provide necessary support if needed).In the meantime, caregivers in the control group will be placed on a waiting list for one month.After this one-month period, post-assessments will be conducted for both groups.Comparisons between the post-assessment and baseline assessment will be used to determine the potential effectiveness of the mobile app intervention.Usage data of the participants in the intervention group will be automatically documented by the system and will be analyzed to explore the relationship between usage patterns and interventional effects.Last but now least, participants in the waiting list control group will be granted access to the app as well after they finish post-assessment.However, this last step is more of an in-kind offer to the participants in the control group which they can refuse if they don't want to have such access.And it is not part of the research procedures, no data or further inquiries will be conducted during this step.Depressive symptoms will be measured by the 20-item Centre for Epidemiological Study Scale (CES-D) (Radloff 1977).Knowledge of dementia will be measured by the 27-item Dementia Knowledge Assessment Scale (DKAS) (Annear, Toye et al. 2015).Caregiving self-efficacy will be measured by the 15-item Revised Scale for Caregiving Self-efficacy (Steffen, McKibbin et al. 2002).Coping strategy will be measured by the 28-item brief Coping Orientation to Problems Experienced (COPE) (Carver 1997).Positive aspects of caregiving will be measured by the 9-item Positive Aspects of Caregiving Scale (PAC) (Tarlow, Wisniewski et al. 2004).Caregiver burden will be assessed using the 22-item Zarit Burden Interview (ZBI) (Zarit, Reever et al. 1980).Anxiety will be assessed by the Generalized Anxiety Disorder 7-item scale (GAD-7) (Spitzer, Kroenke et al. 2006).Mental well-being will be measured by the 22-item Positive Mental Health instrument (PMH) (Vaingankar, Subramaniam et al. 2014).

H5
For the RCT, results will be reported following the Consolidated Standards of Reporting Trials (CONSORT) statement regarding eHealth (Eysenbach and Group 2011).Group information will not be disclosed to the statistician who is in charge of the final analysis, this is to blind the data analyst to reduce bias (Karanicolas, Farrokhyar et al. 2010).The primary analysis will follow the intention-to-treat principle and compare the outcome measures between the intervention vs. control groups.In addition, per-protocol analyses will also be conducted.More specifically, descriptive statistics will be used to describe the participants' profiles and their characteristics.The Mann-Whitney U-test will be used to assess any significant differences in the demographic data and clinical characteristics of the two groups.A multivariate repeated measured ANOVA will be performed to examine the differences between the two groups over time, with the adjustment of potential baseline differences.Effect size (i.e.Cohen's d) will also be calculated.All analysis will be conducted through SPSS V21 or SAS 9.4.The intervention and the assessments are both straightforward and closely related to the study aims, no other tests or assessments will be conducted.As such, we expect that there will be no possibility of incidental findings which have potential health or reproductive importance.Seeking users' feedback phase -after the RCT, a follow-up qualitative interview study with around 20 participants will be conducted to seek users' feedback on the mobile app and to identify features/aspects which can be further improved (final sample size also depends on saturation).No particular selection process will be employed; instead, participants in the intervention group will be invited as soon as they finish the post-assessment.This qualitative interview study will enable a more in-depth evaluation of the app and information generated can be used to further improve the program in potential future studies.For this qualitative sub-study, the interviews will be conducted by the study team members, and will be audio-recorded and transcribed prior to the analysis.Thematic analysis will be conducted.Three researchers will work independently (i.e., Qi, Ellaisha, and Carol) to identify the key themes based on the first few transcripts with a subsequent discussion to refine the code themes, and then to develop the code-book.Disagreement will be solved through further discussion to achieve consensus.All qualitative analysis will be done through NVivo V.11.

I3 Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.
Due to the current COVID situation, caregivers may refuse to join the study due to safety concerns.As such, we will also offer to go through the informed consent and complete the discussion/assessments/interviews online via videoconferencing.This is also to maximize our recruitment.
• No ○ Yes J1 How will potential Research Participants be identified?(Please tick all the applicable boxes) ☑ Referral by attending healthcare professional ☑ Persons with dependent relationship with study team (e.g.doctor-patient, employee-employer, headsubordinate, student-teacher, departmental staff relationship) Please state clearly the dependent relationship of the study team members with the research participants.In addition, please describe how the study team will manage the dependent relationship to prevent coercion or undue influence (e.g.informed consent will not be taken by the primary physician of the participants, sufficent time will be given to the participants for their consideration in the research study and voluntary participation will be emphasized to the participants) For some informal caregivers, their relatives with dementia might be seeking treatment from the clinician who is part of the research team.In this case, the clinician could refer the caregivers to us.Please note that the clinician will not be involved in the consent-taking and interview process.The potential participants will be followed up by other research team members.This is to avoid perceived coercion.Due to the slow recruitment, the principal investigator or the designated staff will go to CGH to receive the collaborating clinician's referral.No other procedures will be conducted in CGH.

Please specify
There are a few different ways to identify the research participants:1) the study team will also actively approach potential participants in the outpatient clinics and ask them if they are looking after a person with dementia to avoid approaching non-dementia caregivers;2) our collaborating clinician may refer informal caregivers of some of their patients to us, and these potential participants will be followed up by the study team members;3) since we will put up the recruitment advertisement online, potential participants who see this advertisement might contact us, we will follow up onwards;4) we may also actively contact some participants from two previous studies (DSRB ref -2016/00921 amp; 2018/01069) who were agreeable to be contacted for future studies to check if they are willing to join;5) participants will also be asked to refer their peers to us.

J2 Will there be direct contact with Research Participants? ○ No
• Yes (i) Who will make the first contact with Research Participants ?For potential participants referred by the clinicians, the clinician will be the first contact point, and then the potential participant will be followed up by the study team members.For all other recruitment methods, one member of the study team or dedicated research assistant will make contact with the research participants.
(ii) How will the Research Participants be contacted ?*Click here for help 1) For participants regularly accompanying the PWDs to visit the IMH satellite clinics, we will approach them face-to-face in the clinics.2)In some circumstances, our collaborating clinician or the participants themselves may refer eligible participants to us.Before we get the referrals, we will emphasize to them to seek potential participants' approval first.The potential participants will be the ones to provide the contact details to pass on to the study team.We will only approach the referred caregivers if they agree to be contacted by us.In this case, we may call or SMS the referred caregivers to follow up.3) For potential participants who contact us after they see the online recruitment advertisement, the study team member will follow up with them through phone calls.4) For caregivers who agreed to be contacted for future studies in our previous research projects (DSRB ref -2016/00921 amp; 2018/01069), we will also contact them through phone call or SMS to check if they are willing to join the current study.5) Caregivers who are referred by their peers will be followed up by the study team via calls or SMS if they are willing to join the study.
( The recruitment flyer might be used in several ways:1) it might be put in the clinics as posters, to enable potential participants who are interested in this study to contact us;2) It might also be put up on social media platforms such as Facebook, Instagram, and Linkedin.We will create specific accounts for the project itself to upload such info.In the meantime, we will approach our corp com to see if possible to put on the official social media accounts of IMH.Last but not least, we will also approach voluntary welfare organizations such as Caregiver Alliance or Alzheimer's Disease Association to see if possible to put on their social media accounts as well.
3) the clinician might also keep copies of the recruitment flyers so that they can distribute them to the caregivers who are potential research participants.For the focus group discussion during the app design and development phase, the discussion will take 1-2 hours, and it will comprise the following procedures:1) obtain written informed consent from all the participants;2) conducting the discussion;3) disbursement of inconvenience fees.For participants in both groups during the pilot RCT, the study will involve completing two assessments which each will last for 1-2 hours.The assessment will comprise the following activities : 1) obtain written informed consent from the participant (only for the baseline assessment);2) complete the assessment;3) disbursement of inconvenience fee.For participants in the intervention group, they will be required to use the app developed by us for one month.They will be advised to use it for at least 30 minutes per week and complete two positive reflection entries, but they will decide how they will use it in reality.The study team will call them on a weekly basis to solve any issues they face while using the app and to motivate them.PHQ-9 will be administered to the participants in the intervention group after week 2 to monitor their mental health, this will take less than 10 minutes.We will also conduct a follow-up interview among some of the participants in the intervention group (the final sample depends on the saturation).This interview will take 30-60 minutes, and it will comprise the following procedures:1) obtain written informed consent from the participant;2) conducting the interview;3) disbursement of inconvenience fee.We may also contact the interview participants within three months upon the completion of the interviews in case we missed anything from the recording.Such contact will be done via phone call and normally won't last for more than 10 minutes.A bit more details on the online content taking process:The video-conferencing platform Zoom will be used to obtain consent from the participants online.One day before the consenttaking session, a soft copy of the ICF together with a document on how to sign a file via an electronic device will be sent to the participant so that they can review these documents in advance.A study team member and witness will be in the consent-taking process alongside the participant.The presence of the witness is to ensure the ICF process is conducted properly.At the start of the Zoom meeting, participants will be requested to show photo identification of themselves to prove their identity.Similarly, the study team will show their IMH staff identification to prove their identities.The study team member will go through the ICF with the participant.After the study team member who is taking the consent clears all doubts of the participant and the participant verbally agrees to sign the ICF to continue the study, the study team member will send an ICF to the participant via email with the witness being in the CC list.The signature will be done in the sequence of 'participant -witnessconsent taker'.Adobe Acrobat Reader (PC) and Adobe Fill amp; Sign (mobile) will be used to obtain electronic signatures, and the individual who is signing will be required to turn on the share screen feature of Zoom to enable others to verify the process.The consent taker will save the ICF into a read-only version after he/she puts in his/her signature, this is to prevent any unauthorized edition on the signed ICF file.The consent taker will send this read-only ICF to the participant afterward, for his/her records.It will also be kept in the secure drive which is only accessible via IMH intranet, and only eligible study team members will be granted the access.

Please
K9: Will a witness be present during the consent process?For studies that are under the purview of the HBRA, consent must be obtained in the presence of a witness, unless the requirements for exemption are met.*Clickhere for help

Not applicable
Not applicable M6 Discuss any potential benefits to the individual Research Participants and/or the population of Research Participants and/or to the society that justify involvement of Research Participants in this study.There is no assurance that the participants might benefit from participation in this study or not.However, their participation in the study may add to the knowledge about the use of this mobile app to support caregivers of persons with dementia in the local context.) and type of data (e.g.adverse events/serious adverse events) will be monitored.*Click here for help Adverse events (i.e., depression) will be monitored.We will call the participants in the intervention group after week 2 to assess their depression status using Patient Health Questionnaire (PHQ-9), participants with a score above 20 will be considered as at severe risk and will be asked to seek treatment with their family physician.These cases will also be reported to DSRB as adverse events.Causal relationships will be assessed following the three criteria for determining causal relationships, including 1) Empirical association -empirically these events should be related to the study or study procedures;2) Temporal relationshipthe event should happen after the intervention is introduced;3) Nonspuriousness -no other possible reasons or explanationsThe study team member conducts the recruitment or the PI will be responsible for assessing the events; the PI will be responsible for managing the events.
(c) Please state the Data Monitoring plan, i.e. frequency of review (e.g.daily, weekly, quarterly), how data integrity is assured.The questionnaire will be checked for discrepancies by the person who administers the interview as soon as the completed questionnaire is collected.The data will be double entered on a monthly basis to ensure data integrity and quality.For FGD and qualitative interview data, the interview process will be audio-recorded.The recorded file will be transcribed verbatim immediately after the interview, and be crossed-checked by another study team member.Data confidentiality will be monitored on a monthly base -the principal investigator will check the hard copy data collection forms to ensure they are all under locked conditions and only accessible to the authorized study team members.We will also call up a monthly meeting with the vendor to let them report the status of the app and the server.This is to monitor the data security status.iHIS will be involved if needed.
O1 Will any biological materials (such as blood or tissue) be used as part of the study?Your DSRB Application is now complete and ready for submission.

Principal Investigator's Declaration
I will not initiate this study until I have received approval notification from the DSRB and all applicable regulatory authorities.
I will not initiate any change in the study protocol without prior written approval from the DSRB, except when it is necessary to reduce or eliminate any immediate risks to the Research Participants.Thereafter, I will submit the proposed amendment to the DSRB and all applicable regulatory authorities for approval.
I will promptly report any unexpected or serious adverse events, unanticipated problems or incidents that may occur in the course of this study.
I will maintain all relevant documents and recognise that the DSRB staff and applicable regulatory authorities may inspect these records.
I understand that failure to comply with all applicable regulations, institutional and DSRB policies and requirements may result in the suspension or termination of this study.
I declare that there are no existing or potential conflicts of interest for any of the investigators participating in this study.
By checking the "I agree" box, you confirm that you have read, understood and accept the Principal Investigator's Declaration ☑ I have read and agree to the above declaration.
Principal Investigator: Qi YUAN Domain F (Section C -Conflict of Interest Declaration) With effect from 1 January 2015, all study team members involved in the design, conduct or reporting of the research are required to complete and endorse a Conflict of Interest Declaration Form annually to the DSRB Financial Conflict of Interest (FCOI) Secretariat.This declaration includes any conflicts of interest of their immediate family members (includes parents, siblings, spouse and each dependent child).The annual Conflict of Interest Declaration Cycle will be from 01 Jan to 31 Jan of the year and the declaration will be valid from 1 Jan to 31 Dec of the same year.The Conflict of Interest Declaration Form may still be submitted beyond the Declaration Cycle.However, the declaration will only be valid until the next Declaration Cycle.The Conflict of Interest Declaration Form can be downloaded from https://www.research.nhg.com.sg/wps/wcm/connect/romp/nhgromp/hspp/financial+conflict+of+interest/fcoi+policy.An updated Conflict of Interest Declaration Form must be submitted to the FCOI Secretariat as soon as possible but no later than 30 days if any of the circumstances relevant described herein change during the conduct of the research.Study Team Member List if there are any study team members (study coordinators, biostatisticians etc.) involved in the design, conduct and reporting of the research, who are not listed in Section B and C of the DSRB Application Form.D1 Please select the Nature(s) of Study that best describes your application ☐ Education Research ☐ Health Services and Outcome Research ☑ Prevention & Health Promotion Programme ☐ Epidemiological Research ☐ Social and Behavioral Research ☐ Community-based Participatory Research ☐ Others D2 Please tick all research method(s) that is/are relevant to your study:* Click here for help ☑ Questionnaire or Survey ☐ Analysis of Existing Data ☑ Focus Group Discussion / Interview ☐ Clinical Research E1.Who will be responsible for the payment and compensation of injury or illness arising from participation of research participants in the study?• National Clinical Trial (CT) Insurance Policy (All public healthcare institutions are covered under this policy.You may contact your institution research office for more information if required.)○ Sponsor ○ Others E2 Please give information regarding the study's Funding source or Sponsor information.○ No funding is required for this study to be carried out ○ Pharmaceutical / Industry Sponsored • Grant/ other source(s) of funding i. Name of Grant Agency and Grant Name (For other source(s) of funding, please select 'Others' and proceed to specify the funding source(s) in the next text box) Others Please specify: NHG Population Health Grant ii.Grant/ funds amount applied for 183,919 iii.Date of Grant/ funding application deadline (For other source(s) of funding, please enter the effective date of the contract) 01-Mar-2021 iv.Has the Grant/ funding application been approved?• Yes.Grant/ funding application successful.grant approval letter or notification of award.However, if your study is a US federally funded research, please attach the approved grant proposal and all relevant documents approved by the grant body (e.g.study protocol, consent form etc.).LOA_App for Dementia Caregivers.pdfApproval of grant extension 1 Jun 2023 _ PHG project (PHG20.P.I.2.6) Design and pilot-test of an innovative mobile-based intervention.pdf○ No. Grant/ funding application is pending approval.○ Financing/Sponsorship from Community Based Agency Are there any recruitment restrictions based on the gender of the research participants?• No ○ Yes H6 Are there any recruitment restrictions based on the race of the research participants?• No ○ Yes H7 Does the study involve any of the vulnerable Research Participants ?☐ Others (e.g.parents, students, residents, house owners) I1 Please list all procedures, measures and analyses that will be performed in this study.If you are extracting data from existing record, please indicate the period of data that will be extracted (E.g. 1 Jan 2000 ï¿½31 Dec 2010) In your list, indicate the procedures that are being done for non-research purposes (i.e Procedures that are performed as part of curriculum / is performed for diagnostic/standard clinical purposes).
indicate the length of time of the Research Participant's direct involvement in the study.E.gFor completion of surveys, focus group discussion, taste evaluation, clinical visits, examinations etc. (If applicable)

M7
Is it appropriate for your research to have a monitoring plan to periodically assess the data to ensure the safety of Research Participants or to ensure negative outcomes do not occur (e.g.physiological stress, employment termination etc)* Click here for help ○ No • Yes (a) Who performs the data and safety monitoring?• Principal Investigator and/ or Study Team ○ Data Safety Monitoring Board (DSMB) (Please submit the DSMB charter) ○ Others (a) Describe the steps that you will be taking to assure that Research Participants are protected.You may attach a copy of the plan null (b) Please state the Safety Monitoring plan, i.e. frequency of review (e.g.daily, weekly, quarterly

•
Non-Exempt (Expedited / Full Board ) ○ Exempt.Please note that if your study does not qualify as exempt, the application for Non-Exempt review must be completed.Please click on "Exempt" to find out more on the list Application Form For Domain F (Section G -Study Information) The prevalence of dementia was about 10% among residents aged 60 years and above in Singapore according to a national study conducted by the Institute of Mental Health in 2013(Subramaniam, Chong et al. 2015), which was equivalent to 51,934 older adults locally (WiSE team and Institute of Mental Health Research Division 2014).One significant concern for persons with dementia (PWD) is that they usually show high dependence and require intensive care, mostly from informal caregivers such as family members(Schulz  and Martire 2004, Brodaty and Donkin 2009, Haro, Kahle-Wrobleski et al. 2014).The global financial cost associated with dementia was reported as US$ 948 billion in 2016, among which 42.3% were from informal care(Xu, Zhang et al. 2017).Similarly, the estimated societal costs of dementia in Singapore had reached SGD 532 million in 2013(Abdin, Subramaniam et al. 2016).Since the population in Singapore is aging, this amount is expected to increase as well.Although caregiving could be rewarding(Kramer 1997, Cohen, Colantonio et  al. 2002), family members caring for PWD at home often describe the experience as enduring, stressful, and frustrating(Butcher, Holkup et al. 2001), making them one of the high-risk groups for potential health issues.Previous research had identified several negative consequences of caregiving, such as caregiver burden (Haro,Kahle-Wrobleski et al. 2014), depressive symptoms(Givens, Mezzacappa et al. 2014), and poor self-perceived physical health

Please provide justification for selection of all the group/population indicated in Section H1 The
current study aims to explore the feasibility and potential effectiveness of a mobile-based intervention on the mental health of local informal caregivers of persons with dementia.As such, caregivers of persons with dementia are the target population for this study.